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Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: Final results of the FinHer Trial
Journal of Clinical Oncology, 11/05/09

Joensuu H et al. – Docetaxel has not been compared with vinorelbine as adjuvant treatment of early breast cancer. Efficacy and long-term safety of a short course of adjuvant trastuzumab administered concomitantly with chemotherapy for human epidermal growth factor receptor 2 (HER2) –positive cancer are unknown. Adjuvant treatment with docetaxel improves DDFS compared with vinorelbine. A brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation.

Methods

1010 women with axillary node–positive or high-risk node-negative breast cancer randomly assigned to receive 3 cycles of docetaxel or vinorelbine, followed in both groups by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC)
Women with HER2-positive cancer (n = 232) further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine
Median follow-up time was 62 months after random assignment

Results

Women assigned to docetaxel had better distant disease–free survival (DDFS) than those assigned vinorelbine
In subgroup of HER2-positive disease, patients treated with trastuzumab tended to have better DDFS than those treated with chemotherapy only
In exploratory analyses, docetaxel, trastuzumab, and FEC improved DDFS compared with docetaxel plus FEC and vinorelbine, trastuzumab, and FEC
Median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during 5-year follow-up
1 woman treated with trastuzumab diagnosed with heart failure

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